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May 21, 2001
RE: Prescribing Information Changes Regarding Baycolâ (cerivastatin sodium tablets)
Dear Health Care Professional:
This letter provides important information on the prescribing of Baycolâ for the treatment of hyperlipidemia. Recently, Bayer Corporation has voluntarily made changes to the prescribing information for Baycolâ in order to provide prescribers and patients with more specific guidance on initiating therapy with the product. These changes are:
Bayer Corporation has made these revisions because we have received reports of muscle weakness and rhabdomyolysis during the post-marketing period. A substantial number of these cases occurred in patients receiving Baycolâ in a manner inconsistent with product labeling: e.g. patients were treated with concurrent gemfibrozil therapy and/or received Baycolâ 0.8mg as a starting dose. Rhabdomyolysis has been reported with all statins and is reflected in the corresponding prescribing information for all statins.
In December 1999, Bayer Corporation changed the Baycolâ prescribing information to include a contraindication with gemfibrozil. The combined use of cerivastatin and gemfibrozil is contraindicated due to a risk for rhabdomyolysis and concurrent use should not occur under any circumstances.
Patients taking Baycolâ or any other statin should be advised to report promptly to their physician unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.
We are making the above-mentioned prescribing revisions because appropriate use of Bayer products and patient safety are the primary concerns of Bayer Corporation. When used as directed, Baycolâ effectively and safely treats patients with hyperlipidemia.
Please refer to the enclosed prescribing information or Bayer Corporation website at http://bayerpharma-na.com for the prescribing information. If you have further questions regarding this change to the prescribing information, please contact Bayer Clinical Communications at 1-800-288-8371.
Sincerely,
Richard K. Goodstein, MD
Vice President, Scientific Relations
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